Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2018-04-04
2020-04-01
Brief Summary
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The investigators want to explore whether this program will improve health-related quality of life and psychological well-being in patients. In addition they want to explore its potential positive modulation of the immune system.
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Detailed Description
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Hypothesis: Yoga program based on Yoga in daily life system has positive impact on clinical and biologic outcomes in RA patients.
Aims: To determine the impact of a 12-week yoga program on measures of psychological distress, HRQOL, fatigue, pain, disease activity, levels of circulating inflammatory markers and pro-inflammatory gene expression.
Materials and methods: 50 RA patients, aged 18-65 years, on stable standard pharmacological treatment will be randomly assigned to a 12-week yoga intervention (based on "Yoga in daily life system") or arthritis-education control. Self-administered questionnaires will be used to assess quality of life and psychological well-being of the patients. Blood samples will be collected for measurement of inflammatory markers and expression of a set of pro-inflammatory genes. Disease activity will be assessed by DAS28CRP score. The patients will be assessed on baseline, post-treatment and at 3 months follow-up.
This research will provide information on potential efficacy of yoga program in improving physical and psychological outcomes in persons with RA and explore its influence on immunological system.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Yoga program
12 weeks of "Yoga in daily life practice", 2x weekly for 90 minutes including physical exercises (asanas), breathing exercises (pranayama), relaxation and meditation exercises.
Yoga program
Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.
Arthritis-education control
12 weeks of arthritis - education classes, consisting of 1x weekly sessions for 120 minutes including lectures on arthritis and related issues followed by group discussion.
Arthritis-education
Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.
Interventions
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Yoga program
Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.
Arthritis-education
Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.
Eligibility Criteria
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Inclusion Criteria
2. disease activity measured by DAS28CRP\< 5.1
3. patients on stable dose of disease-modifying antirheumatic medications,non-steroidal anti-inflammatory drugs or low-dose glucocorticoids for the last 3 months
Exclusion Criteria
2. history of drug or alcohol abuse
3. recent injury/ or surgery
4. regular practice of yoga or similar technique in the last 6 months or currently engaged in a structured exercise program for \>=2 times weekly, patients that are currently engaged in physical therapy
5. pregnant or planning pregnancy
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Dubrava
OTHER
Responsible Party
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SILVA PUKŠIĆ
MD, PhD candidate
Principal Investigators
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Silva Pukšić, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Dubrava
Jadranka Morović-Vergles, MD, PhD
Role: STUDY_CHAIR
University Hospital Dubrava
Locations
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University Hospital Dubrava
Zagreb, , Croatia
Countries
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Other Identifiers
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DUBRAVA-YOGRA-01
Identifier Type: -
Identifier Source: org_study_id
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